CooperVision, Inc. recalls Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moul…
- Recall date
- August 22, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2607-2025
- FDA classification
- Class II
- Brand / firm
- CooperVision, Inc.
- Sold / distributed
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
Why it was recalled
One lot manufactured with an invalid sterilization cycle.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel, In-monomer tinted, contact lens, for Daily Disposable Wear. Blister packaged.
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